NCT03277742

Brief Summary

The objective of this study is to evaluate an integral strategy in which diabetes mellitus 2 (DM2) and pulmonary tuberculosis (TB) are managed together. The researchers propose a community intervention with two arms in 4 health centers in Orizaba, Veracruz. Patients will be assigned to either arm by convenience. One arm will receive the joint treatment strategy and another the routine treatment used in health services.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

September 20, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

2.6 years

First QC Date

September 7, 2017

Last Update Submit

May 13, 2020

Conditions

Pulmonary TuberculosisDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • Treatment success

    Bacteriological cure using sputum smear and culture

    Up to 6 months

  • Blood glucose control

    mg/dl

    Up to 6 months

Study Arms (2)

Control

ACTIVE COMPARATOR

This arm will receive the standard of care for patients with TB and DM2

Drug: Standard of care

Intervention

EXPERIMENTAL

This arm will receive the community intervention

Behavioral: Community intervention

Interventions

Community interventionBEHAVIORAL

Training of patients, health personnel and community health workers. Bidirectional screening. Monitoring blood glucose levels. Home visits. Medical referral. DOTS.

Intervention
Standard of careDRUG

DOTS plus standard DM2 care

Control

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of active PTB, Diagnosis of DM2, Not having started TB treatment, Attend a selected health clinic, Sign a written informed consent

You may not qualify if:

  • Unable to provide information, Pregnancy, HIV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Salud Camerino Mendoza

Orizaba, Veracruz, Mexico

Location

Related Publications (4)

  • Martinez-Aguilar G, Serrano CJ, Castaneda-Delgado JE, Macias-Segura N, Hernandez-Delgadillo N, Enciso-Moreno L, Garcia de Lira Y, Valenzuela-Mendez E, Gandara-Jasso B, Correa-Chacon J, Bastian-Hernandez Y, Rodriguez-Moran M, Guerrero-Romero F, Enciso-Moreno JA. Associated Risk Factors for Latent Tuberculosis Infection in Subjects with Diabetes. Arch Med Res. 2015 Apr;46(3):221-7. doi: 10.1016/j.arcmed.2015.03.009. Epub 2015 Apr 10.

    PMID: 25864989BACKGROUND

  • Riza AL, Pearson F, Ugarte-Gil C, Alisjahbana B, van de Vijver S, Panduru NM, Hill PC, Ruslami R, Moore D, Aarnoutse R, Critchley JA, van Crevel R. Clinical management of concurrent diabetes and tuberculosis and the implications for patient services. Lancet Diabetes Endocrinol. 2014 Sep;2(9):740-53. doi: 10.1016/S2213-8587(14)70110-X.

    PMID: 25194887BACKGROUND

  • Delgado-Sanchez G, Garcia-Garcia L, Castellanos-Joya M, Cruz-Hervert P, Ferreyra-Reyes L, Ferreira-Guerrero E, Hernandez A, Ortega-Baeza VM, Montero-Campos R, Sulca JA, Martinez-Olivares Mde L, Mongua-Rodriguez N, Baez-Saldana R, Gonzalez-Roldan JF, Lopez-Gatell H, Ponce-de-Leon A, Sifuentes-Osornio J, Jimenez-Corona ME. Association of Pulmonary Tuberculosis and Diabetes in Mexico: Analysis of the National Tuberculosis Registry 2000-2012. PLoS One. 2015 Jun 15;10(6):e0129312. doi: 10.1371/journal.pone.0129312. eCollection 2015.

    PMID: 26075393BACKGROUND

  • Ait-Khaled N, Enarson DA, Bencharif N, Boulahdib F, Camara LM, Dagli E, Djankine TK, Keita B, Karadag B, Ngoran K, Odhiambo J, Ottmani SE, Pham DL, Sow O, Yousser M, Zidouni N. Implementation of asthma guidelines in health centres of several developing countries. Int J Tuberc Lung Dis. 2006 Jan;10(1):104-9.

    PMID: 16466046BACKGROUND

MeSH Terms

Conditions

Tuberculosis, PulmonaryDiabetes Mellitus, Type 2

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Duadalupe Delgado Sanchez, PhD

    Instituto Nacional de Salud Pública

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Level I National Researchers System

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 11, 2017

Study Start

September 20, 2017

Primary Completion

May 1, 2020

Study Completion

December 1, 2020

Last Updated

May 15, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)